Because treating a child with heavy medication has far-reaching implications, parents wonder whether using psychiatric drugs is the best way to help their children with bipolar disorder.

… you might be surprised to find that what you’re reading is far from a balanced consideration of the true risks and benefits of psychotropic medication and polypharmacy in children. Instead, what you get is an out-and-out endorsement for drugging children, fast and furious.

I understand the reason why a parent would be afraid to medicate their child. There are often serious and unknown side-effects to consider. But parents also need to consider that there may be a downside to not medicating and missing an opportunity to interrupt the course of a serious illness. … Not medicating may also carry with it risks.

Don’t you think it’s more fair to say that there IS a free lunch for some (medical experts, or “key opinion leaders” as they’re referred to by pharmaceutical companies) but NOT for others (children subjected to the horrors of polypharmacy and the mortal risks included therein)?

What they forgot to mention

Wozniak, Carlson, and the other experts quoted by USA TODAY neglected to include a few key facts that parents struggling to decide whether or not they should medicate their children for so-called “pediatric bipolar disorder” DEFINITELY ought to consider:

1. The relatively recent (we’re talking mid-90s) rise of the idea that so-called “bipolar disorder” is not an almost exclusively adult phenomenon but a widespread pediatric disease which must be aggressively treated with hardcore psychotropic medications, possibly for life. Authors Joseph Biedermann and Janet Wozniak’s turn-of-the-millennium publications put forth this cash cow of an idea and jump started the 4000% increase of this diagnosis in children between 1994 and 2003.

2. Biedermann et al also established – at (coincidentally!) the very same time – a lucrative partnership with Johnson & Johnson, which generously provided grant funding for the “Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital” in 2001. A report to the funders (that would be J&J) dated 2002 reads, in part:

An essential feature of the Center is its ability to conduct research satisfying… [certain] criteria…. [including that] it will move forward the commercial goals of J&J.

…many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events….

Through the funding provided by J&J, we [the J&J Center for Pediatric Psychopathology] are creating a team of investigators focusing on the following issues:

…We will generate and publish data on the efficacy and safety of medications for improving currently available treatment options for child psychopathology. This work is an essential precursor to the … widespread use of medications

[more on Biedermann and Wozniak’s collusion with J&J to carve out a market for Risperdal in the pediatric population here.]

Thanks to the tireless work of the “J&J Center for Pediatric Psychopathology,” the marketing of antipsychotics to children became so acceptable that pharma sales reps could leave these Risperdal-branded legos in pediatricians’ and psychiatrists’ offices around the country.

4. And finally, for children and adults alike, the Physician’s Desk Reference warns that use of antipsychotics can cause suicidal ideation, aggression, and violence. For example, the entry for Seroquel lists “thoughts of suicide or dying,” “feeling very agitated or restless,” “new or worse irritability,” “acting aggressive, being angry, or violent,” “acting on dangerous impulses,” and “mania” as symptoms that may occur in conjunction with use of Seroquel.

Final Thoughts

Bipolar disease is treatable, that’s the most important thing. I always tell young people who are at the beginning of treatment that bipolar is bad, but now is a great time to get it.

Let’s be real: now is a great time for children to get themselves prescribed a whole bunch of pills under the guise of treating their “lifelong, chronic, REAL bipolar disorders,” so that Wozniak and friends might partake in their free lunches.

But are those lunches really free if the children are the ones paying for them?

To paraphrase a recently released pharmaceutical industry investment report, your 10 year antipsychotics money-making forecast is as follows: partially cloudy skies in 2011 will give way to full sun by 2021.

In other words, antipsychotic patent expirations will be tempered by the emergence of new BLOCKBUSTER antipsychotic drugs, and investors can expect to make a PILE of money by 2021.

The 208 page report, produced by the market research firm of Decision Resources, goes on to make the following predictions:

sales for schizophrenia therapies will drop from $7.4 billion in 2011 to $6.5 billion in 2014 in the developed world, as people switch to newly available generics

the launch of new drug therapies will increase profits thereafter to $8 billion by 2021

these will include glutamine reuptake inhibitors, which will be marketed as “adjuncts” to antipsychotics which address the so-called “negative” symptoms of schizophrenia (apathy, catatonia, low self-esteem, etc.) and are expected to achieve blockbuster status

also included are injectable atypical antipsychotics, sales of which will more than double from $1.4 billion in 2011 to $3 billion in 2021

Well, I’d like to try my hand at a little forecasting myself. In order for those 8 billion buckaroos (or more!) to find their way into the right pockets, I expect we’ll see:

Heavy recruitment of key “opinion leaders” by pharma, supposedly unbiased researchers and clinicians whose endorsements for pharma products are bought and paid for by way of massive bribes (er, I mean funding) for “research” with predetermined outcomes, specifically designed to promote pharma’s commercial interests.

A whirlwind of publications promoting the use of long-acting antipsychotic injections, glutamine reuptake inhibitors, the need for polypharmacy in the treatment of schizophrenia, or any combination therein

A concerted effort at a.) expanding the members of the population that could be construed as suffering from so-called “schizophrenia” b.) expanding the list of other uses for these drugs, including any and all known or as-yet-unknown “diseases” and “conditions” (even if they must be created out of thin air) and c.) further ingraining the idea that conditions which require the use of these drugs are serious, chronic, and require probably lifelong use of patented medications – no generics, please!

If required by the myth-building machine that will lay the foundation for the forthcoming BLOCKBUSTER drugs, paradigm shifts away from currently accepted ideas (perhaps the general public’s abhorrence of forcibly injected, mind-altering drugs? Or a sly admittance that the whole “dopaminergic” hypothesis regarding the biological cause of schizophrenia was, perhaps, maybe, incorrect?)

The logic behind this forecast is simple: it’s exactly what was done by pharmaceutical companies to promote blockbuster atypical antipsychotics 10 years ago. And why get creative when the scam worked so well the first time around?

The scam that worked so well

A lot of internal documents never meant for public eyes have come to light in the recent litigation against Johnson & Johnson for Medicaid fraud and the off-label marketing of RISPERDAL. Two delightful samples will be dissected below:

Early in Gorsky’s deposition, we learn that the Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital, headed up by Dr. Joseph Biederman, was established by a grant from J&J and its affiliates for $500,000 in 2001. The center was described in an internal J&J email as “a great way to get the word [about RISPERDAL] out to a big part of the child and adolescent prescribing community.” This was a full 5 years before Risperdal was approved for pediatric use.

And if the name “Joseph Biederman” sounds familiar, that’s because Biederman is commonly acknowledged as the originator of the idea that childhood bipolar disorder is, in fact, a widespread pediatric disease which must be aggressively treated with medications, specifically antipsychotics. His turn-of-the-millennium publications with Janet Wozniak are credited with jumpstarting the 4000% increase of this diagnosis in children.

More recently, Biederman gained notoriety for some seriously scandalous behavior: he guaranteed J&J company representatives favorable outcomes for a 2005 trial of RISPERDAL in preschoolers. This did tarnish his reputation a little, but by no means did it motivate any of the institutions for which he works (Harvard Medical School, Massachusetts General Hospital) to dismiss him.

Interesting aside: As Bob Fiddaman reports on his blog, here’s an excerpt from an earlier (Feb, 2009) deposition from Dr. Biederman: when asked what rank he held at Harvard, he answered “Full professor.” “What’s after that?” asked a lawyer, Fletch Trammell.“God,” Dr. Biederman responded.“Did you say God?” Mr. Trammell asked.“Yeah,” Dr. Biederman said.

What you’ll see in the documents below is that 2005 was not the beginning of Biederman’s agreement with J&J to produce favorable results validating the research conclusions they specified in advance; that’s been going on at least since 2001, and perhaps earlier.

And what exactly did Johnson & Johnson want him to prove? That there is such a thing as childhood bipolar disorder. It’s a brain disease, likely chronic, that requires lifelong medication adherence. And most importantly: kids need to be taking RISPERDAL.

An essential feature of the Center is its ability to conduct research satisfying… [certain] criteria…. [including that] it will move forward the commercial goals of J&J.

Considering that nearly all psychiatric medication use in children is off label, studies of safety and efficacy in children are essential for clinicians, parents, and patients to feel comfortable using these medications in children… Equally important to effective use of medications is the demonstration of the validity of disorders. Because parents, patients, and clinicians are exposed to a media that frequently questions the validity of childhood disorders, genetic and brain imaging studies are needed to show the validity of these disorders as brain disorders that respond to medication. Epidemiologic studies are needed to show that childhood disorders are frequently chronic and severely debilitating. Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events….

Through the funding provided by J&J, we [the J&J Center for Pediatric Psychopathology] are creating a team of investigators focusing on the following issues:

We will generate and publish data on the efficacy and safety of medications for improving currently available treatment options for child psychopathology. This work is an essential precursor to the … widespread use of medications given that most must be used off-label.

[by the way, Gorsky is positively the most skilled waffler I have ever encountered! Twice in the deposition he admits to having given the opening address at a meeting (it was, unfortunately for him, noted in the agenda), but can’t recall having been there or any of the other things said, and even goes so far to suggest that he may have given the opening address but then, somehow… left. Maybe he was the guy they sent to pick up lunch…]

Gorsky, is that you??

Scientific “research” to further Johnson & Johnson’s commercial aims

Q. You see this document is called “Annual Report 2002: The Johnson & Johnson Center for Pediatric Psychopathology at the Massachusetts General Hospital“?… And the director is Joseph Biederman, M.D., whom we’ve spoken about a couple times today, right?
A. Yes.
Q. Let’s turn to page 861, please, Mr. Gorsky, which is it is executive summary of the annual report. The first sentence of the overview says that “The mission of the Center is…a strategic collaboration between Johnson & Johnson and the Pediatric Psychopharmacology Research Program at the Massachusetts General Hospital.” Is that correct?
A. Yes, that’s what it says.
[…]Q. Let’s turn to the next paragraph, Mr. Gorsky. It says, “An essential feature of the Center is its ability to conduct research satisfying three criteria. . .” Did I read that right?A. Yes.Q. And if we look at the third criteria, it says “it will move forward the commercial goals of J&J.” Is that correct?[…Gorsky tries and fails to avoid answering this question. Finally…] A. Yes.Q. So, this annual report from the Johnson & Johnson Center For Pediatric Psychopathology from 2002 admits that information and research from this supposedly unbiased research center is to benefit the business of sales for Johnson & Johnson. Is that correct? … And commercial goals would include sales of pharmaceuticals. Is that right?A. Yes, it would.

Promoting the widespread use of medication, specifically RISPERDAL, in children

Q. Okay. And then if we look at the next sentence from the annual report, it says “We strongly believe that the Center’s systematic scientific inquiry will enhance the clinical and research foundation of child psychiatry and lead to the safer, more appropriate and more widespread use of medications in children.” Did I read that correctly?A. Yes, you did.Q. So…one of the goals of this center’s inquiry is to lead to the more widespread use of medications in children. Is that right?A. […extensive verbage from Gorsky, followed by…] yes.Q. … Mr. Gorsky, let’s look at the next sentence, where it says “Considering that nearly all psychiatric medication use in children is off label. . .”Q. Do you see that?A. Yes, I do.Q. And that would include Risperdal because in 2002, I think we’ve already agreed, Risperdal was not approved for use in children and adolescents. Is that right?A. Based upon our earlier conversation, it did not have the specific indication at that time, that’s correct.[…]

Producing lifelong RISPERDAL customers

Q. And it [the J&J Research Center’s 2002 Annual Report] says — and this is interesting — “Showing how pediatric mania evolves into what some have called mixed or atypical mania in adulthood will provide further support for the chronic use of RISPERDAL from childhood through adulthood.”Do you see that?A. Yes, I do.Q. So, one of the specific goals of the center is to show that pediatric mania will evolve into mania in adulthood, which will then require the chronic use of Risperdal from childhood to adulthood. Is that right?A. […much waffling, and then…] I think if that was the goal as outlined, that was a reasonable research objective. […]Q. And the continuation of Risperdal from childhood to adulthood would be one of those –remember back in the beginning of this document we saw the word there were commercial goals of Johnson & Johnson, right?A. Yes, I did see that.Q. All right. And the continuation of a Risperdal prescription from a young man or young boy through adulthood would be a commercial goal of Risperdal, right? Or of Johnson & Johnson, I’m sorry.A. Successful treatment of patients, if they were responsive on the medication, for them to stay compliant on the medication would be one of our goals, but only if the drug was working and the patient was living better.Q. So, the way I interpret this is that Johnson & Johnson and Massachusetts General Hospital and Dr. Biederman are collaborating to validate a lifetime use and treatment with Risperdal. Is that correct?A.[…further waffling…]

Mental illness is a biological disease like any other… Schizophrenia is just like diabetes!

It is the mantra of mainstream psychiatry.

And the typical justification presented for the continued repetition of this mantra (despite its being patently false, both from a subjective and objective point of view) is the theory that characterizing “mental illness” as a brain disease reduces stigma. The general public won’t blame afflicted individuals once they realize that it’s just a matter of faulty chemicals, a somewhat defective brain. They won’t fear the disease if they believe that lifelong, routine injections of a necessary but missing chemical (like an insulin shot!) will solve the problem.

Here’s an example of the mantra (and its accompanying justification) in action, from Glen Close’s highly publicized “Bring Change 2 Mind” campaign to decrease the stigma of mental illnesses:

LEARN THE FACTS

One of the best ways you can help someone with mental illness is by understanding what it is – and what it isn’t. After all, myths about mental illnesses contribute to stigma…

The fact is, a mental illness is a disorder of the brain – your body’s most important organ – and 1 in 6 adults lives with a brain-related illness including depression, bipolar disorder, PTSD and schizophrenia… And just as with most diseases, mental illnesses are no one’s fault.

LEARN THE ACTUAL FACTS

First of all, there’s NO KNOWN WAY to measure the balance of chemicals in someone’s brain. No method of establishing what a so-called “normal” balance of chemicals would be. Even if there WERE a method for measuring this, there’d be no reason to assume that this would somehow be universal across people of disparate genetic, biological, cultural, emotional, environmental backgrounds – which mainstream psychiatry seems bent on doing.

Second, numerous (far too numerous to list here!) studies show that a variety of factors besides “biological” ones – ie, the introduction of new chemicals, in the form of pharmaceuticals, into someone’s body – have a profound effect on the resolution of mental and emotional distress. To list one simple example, outcomes for first-episode psychosis (typically leading to a diagnosis of “schizophrenia”) are very different in industrialized societies and non-industrialized societies, because the standard of care is different: industrialized societies emphasize medication as first-line and perhaps the only treatment, while non-industrialized societies emphasize social support and integration into the community combined with little or (more often) no medication. Here’s another great article that goes through a few more examples of how culturally specific mental and emotional distress (and our reactions to it!) can be.

That’s right, folks: the disease model, describing mental and emotional distress as mere chemical imbalances of the brain, is not only false – spreading that falsehood markedly increases stigma! So when mainstream psychiatry claims it may need to tell a “white lie” about all this for the patients’ own good (reduce stigma, get folks to take their meds, etc.) they’re wrong again.

In 1997, Sheila Mehta of Auburn University conducted a simple experiment to test the stigma produced by a disease-based explanation of so-called “mental illness” and a psychosocial one. 55 male college students were enrolled in an experiment. Each one was told that he and a partner would have to do a simple learning task – but the partner was actually a confederate in the study. The confederate would disclose a mental illness to the subject, and then explain either that he had this illness because of “the kind of things that happened to me when I was a kid” [psychosocial] or that he had “a disease just like any other, which affected my biochemistry” [biochemical].

It turned out the group presented with the biochemical explanation were far more likely to treat their partners harshly than the group presented with the psychosocial one. Says Mehta, “The results of the current study suggest that we may actually treat people more harshly when their problem is described in disease terms. We say we are being kind, but our actions suggest otherwise… Viewing those with mental disorders as diseased sets them apart and may lead to our perceiving them as physically distinct. Biochemical aberrations make them almost a different species.”

Later studies (like this one involving over 450 people in New Zealand) have replicated Mehta’s results and agreed with her conclusion. What’s that mean?

It’s actually SCIENTIFICALLY SOUND

unlike the disease-based “biochemical imbalance of the brain” theory, which has still not been proven true, in part or in whole, despite over 40 years of extremely well-funded studies directed towards that very specific purpose.

We do not know the causes [of any mental illness]. We don’t have the methods of ‘curing’ these illnesses yet.

[While] there has been no shortage of alleged biochemical explanations for psychiatric conditions…not one has been proven. Quite the contrary. In every instance where such an imbalance was thought to have been found, it was later proven false.

-Dr. Joseph Glenmullen, Harvard Medical School psychiatrist

[today’s dose of sarcasm will be footnoted]

*A few other goodies from the “Bring Change 2 Mind” website

An image of Glen Close and her BIPOLAR sister.

See the difference – one person is NORMAL, and the other is BRAIN-DISEASED. It says it on their shirts! (Not stigmatizing at all…) And for the mere price of $20 a pop you, too, can wear an anti-stigma shirt with your diagnosis printed clearly across the front, labeling you.

Anyone? Anyone at all want to fight stigma by labeling and stigmatizing yourself?

I think this is a far better way to fight stigma — rip those labels up!

Two studies with nearly identical data yield very different conclusions. Beautiful lady or old hag? Both collected data showing that individuals initially receiving a diagnosis of “depression” and treatment with antidepressants convert to “bipolar” diagnoses at an impressively high rate.

But the survey released today (in honor of the UK’s “National Bipolar Awareness Day”) by Bipolar UK portrays the data on conversion as evidence of misdiagnosis and the need for better awareness of bipolar disorder by mental health professionals, while this study from 2004 attributes conversion, not to misdiagnosis, but largely to antidepressants’ tendency to cause mania (it is a PDR-listed side effect, after all).

I read the executive summary of your recent survey of individuals diagnosed as “bipolar” with great interest. I was particularly struck by two statistics you presented:

- 85% of respondents were diagnosed with and treated for depression before being diagnosed as bipolar

- 71% of those receiving delayed diagnosis felt that their symptoms had been made worse by antidepressants or sleeping pills

Your data reminds me of a widely cited 2004 study in which 87,920 individuals initially diagnosed with depression were followed for 5 years. 4182 eventually received a diagnosis of bipolar (“converted”) during the course of the study, and 81% of them were being treated with antidepressants. The authors state in their analysis that “the conversion rate amongst antidepressant-treated patients (7.7% per year) was 3-fold that amongst unexposed patients (2.5% per year).” These findings are quite consistent with yours.

Your interpretation of this data seems to be that the timely diagnosis of bipolar disorder is an area that needs improvement amongst mental health professionals, who currently are misdiagnosing many bipolar individuals with depression.

However, I would like to suggest to you another interpretation, one that the previously cited study puts forward. Its authors state that “It has long been known that antidepressant medications can precipitate mania in vulnerable individuals” and that “treatment with antidepressants is associated with … conversion hazards.” “Mania/hypomania” are also listed in the Physician’s Desk Reference as effects of both SSRIs and tricyclic antidepressants. The PDR entry on imipramine (the very first tricyclic antidepressant) explicitly states “Manic or hypomanic episodes may occur; consider decrease until episode is relieved.”

Is it possible that many of the respondents to your survey, and many of the individuals you serve – in short, people with “bipolar” diagnoses – are dealing with an entirely iatrogenic phenomenon?

On this inaugural “Bipolar Awareness Day,” I think it is vital that we pursue awareness, not only of the diagnostic criteria, but also of the very real possibility of diagnostic inflation that is iatrogenic in nature.